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Researchers are studying acute pyelonephritis (AP), a common bacterial kidney infection in children, focusing on those aged 1 month to less than 3 years without prior urological malformations. The study compares a short 3-day intravenous (IV) antibiotic treatment alone to a 3-day IV treatment followed by 7 days of oral antibiotics. The goal is to see if the shorter IV-only treatment is as effective at preventing infection recurrence and long-term kidney scarring, while possibly reducing antibiotic resistance and preserving gut microbiota diversity. Participants receive either IV ceftriaxone and/or amikacin once daily for 3 days, or the same 3-day IV treatment followed by 7 days of oral cotrimoxazole or cefixime. The study includes procedures like procalcitonin testing and fecal or rectal swabs collected at several points during and after treatment (day 0, 3, 10 or 17, and 31 or 38) to monitor bacterial presence and gut microbiota changes. Treatment begins after initial confirmation of infection and favorable early response. During the study, children are closely monitored for infection recurrence 28 days after completing antibiotics. Assessments include clinical evaluations, urine cultures, and monitoring for any adverse effects. The total participation covers treatment and follow-up periods to ensure safety and measure outcomes such as infection recurrence and bacterial resistance. This is a Phase 4 open-label randomized trial conducted across multiple centers.

This research focuses on patients with isolated anterior cruciate ligament (ACL) ruptures, which can occur in different parts of the ligament, including proximal areas. The study aims to evaluate the relapse rate at 5 years in patients who underwent surgical repair for a proximal ACL tear. The study also considers the background of treatment options, including functional treatment for low-demand patients and surgical treatment, especially for athletes who face a higher risk of re-injury. Surgical treatment in this study involves repairing the proximal ACL rupture, a method that has gained renewed interest due to new fixing systems. This repair is an alternative to the commonly used ligamentoplasty, where a knee tendon replaces the ruptured ACL. The study includes patients who had surgery between January 2019 and July 2021. It focuses specifically on those with proximal Sherman 1 or 2 ACL tears, sometimes with associated meniscal or grade 1-2 collateral ligament injuries. Participants will be followed for 5 years after surgery to assess the rate of ACL rupture relapse. Researchers will monitor the long-term outcomes of this surgical repair technique, which has limited long-term data available. The study will consider patient history, physical examination findings, sports participation, and other factors to understand the effectiveness and durability of the repair over time.

Researchers are evaluating the efficacy and safety of Synolis VA 80/160 in treating symptoms of hip osteoarthritis over a period of 6 months. This multicenter, independent study focuses on adults with hip osteoarthritis confirmed by specific clinical and radiographic criteria. The study aims to assess patient outcomes using measures like the Oxford Hip Score to track improvements in hip pain and function. Participants will receive Synolis VA 80/160, a device containing hyaluronic acid 80 mg and sorbitol 160 mg, designed to be injected into the hip joint. The study includes patients who have experienced inadequate relief from standard pain treatments and have not had prior injections in the target hip within the last 6 months. The treatment and follow-up periods extend over 6 months to monitor effects and safety. Throughout the study, participants will be monitored for changes in hip pain and function using the Oxford Hip Score at 6 months. Assessments include clinical evaluations, radiographic imaging, and safety observations. Participants’ adherence and responses will be tracked to evaluate the treatment's impact on hip osteoarthritis symptoms and overall patient well-being during the study period.

This research aims to evaluate the effects of litifilimab (BIIB059), a monoclonal antibody, in adults with active subacute or chronic cutaneous lupus erythematosus (CLE), with or without systemic lupus erythematosus (SLE). Participants have active skin symptoms of CLE that have not improved with antimalarial therapy or had difficulties continuing that treatment. The study focuses on reducing skin disease activity using several scores including CLA-IGA-R and CLASI, while also assessing safety, immune response, and quality of life. Participants will be randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks during a 24-week double-blind period where neither participants nor researchers know which treatment is given. After this, all participants will receive litifilimab injections every four weeks for an additional 28 weeks. Those who complete the treatment may join a long-term extension study or enter a follow-up safety period lasting up to 24 weeks. Total participation may last up to 80 weeks. Throughout the study, researchers will monitor skin disease activity using the CLA-IGA-R erythema score and the CLASI-A activity score to see how many participants improve. They will also assess safety, tolerability, immune system effects, and participants' quality of life using questionnaires. These evaluations occur regularly during both treatment periods and follow-up to understand the impact of litifilimab on CLE symptoms and overall health.

Researchers are monitoring the use of the Virtue4 Male Sling System in men with stress urinary incontinence following prostate surgery. This study aims to collect real-world medical data on the device's effectiveness and safety over a period of 12 and 36 months after implantation. The study is a multicenter, prospective, non-interventional follow-up involving urologists experienced with the device. The Virtue4 Male Sling is an implantable device made of polypropylene mesh designed to support the urethra and treat male stress urinary incontinence caused by intrinsic sphincter deficiency. Participants receive the device through surgical implantation, and their progress is tracked during routine clinical visits. Follow-up visits occur around baseline (preoperative and implantation), between 1 and 3 months post-operation, and at 12 months. Afterward, annual questionnaires are mailed for two more years to continue monitoring. Participants are involved in routine clinical care with additional questionnaires to assess their condition. Researchers evaluate patient-reported improvement and monitor any adverse events at 12 months. The total study duration includes follow-up up to three years post-implantation, allowing long-term observation of device performance and safety in a real-world setting.

Type 2 diabetes and obesity are complex diseases influenced by interactions between genes and the environment. This research aims to better understand how different physical traits affect gene activity in tissues involved in glucose and fat metabolism. The study focuses on the link between obesity and diabetes, sometimes called "diabesity," by examining genetic factors and biological pathways in humans and animal models. Participants who require abdominal surgery, such as bariatric surgery or gallbladder removal, will provide biological tissue samples. The study includes people with varying body mass indexes (BMI) and glucose levels, with groups ranging from severely obese with diabetes to lean individuals without diabetes. Researchers will use advanced genetic and bioinformatics techniques to analyze these samples and explore gene expression patterns. During the study, participants will be assessed before surgery, and tissue samples will be collected during the procedures. Researchers will study how physical and metabolic characteristics influence gene behavior related to diabetes and obesity. The main outcome is to analyze gene expression in tissues involved in glucose metabolism at the start of the study. The research involves participants aged 18 to 65 and monitors their biological data to improve understanding of these intertwined conditions.

Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental. Better knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome. In this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.

Research shows that women who experience interpersonal violence are at a higher risk of developing post-traumatic stress disorder (PTSD). In France, female victims can request a medico-legal examination in clinical forensic medicine units, which also offer initial psychological evaluations. However, many women do not attend follow-up appointments. This trial aims to evaluate the effectiveness of a case management algorithm using early phone contact compared to usual care on clinical outcomes after such consultations for female victims of violence. Participants in the intervention group, called VIGITRAUMA, will receive a phone call three weeks after their initial consultation, with the possibility of a second call. If contact is not made after the second call, a postcard will be sent. The control group will receive the standard follow-up care without additional phone contact. The study is a prospective, multicenter, open-label, randomized controlled clinical trial involving women victims of violence. Women enrolled will be evaluated via phone at 3 months, 6 months, and 12 months following their consultation to assess clinical outcomes related to PTSD and violence-related symptoms. The study monitors the effectiveness of early phone contact in improving these outcomes and reducing the risk of PTSD development among participants.

Researchers are evaluating the safety and effectiveness of ifinatamab deruxtecan (I-DXd) alone or combined with other treatments in people with metastatic castration-resistant prostate cancer (mCRPC). This study aims to understand how well patients tolerate the treatment, find a safe dose for combining I-DXd with other drugs, and measure prostate-specific antigen (PSA) levels during treatment. The study is part of a larger master screening protocol and includes patients with confirmed prostate adenocarcinoma who have progressive disease despite prior therapies. Participants receive treatments including I-DXd given through intravenous infusion, sometimes combined with other drugs such as docetaxel (IV), MK-5684, abiraterone, or enzalutamide (all oral). Before each I-DXd dose, patients take premedication to prevent nausea and vomiting. The study includes both a safety lead-in phase and an efficacy phase, with ongoing monitoring for side effects and tolerability. The combination therapies are carefully dosed and scheduled according to the study protocol. During the study, participants undergo regular assessments to monitor side effects, measure PSA response, and track any dose-limiting toxicities. Safety is closely followed, particularly during the first 21 days for combination treatments, and throughout up to 54 months for long-term outcomes. Researchers also observe if participants discontinue treatment due to adverse events. The study requires ongoing visits and evaluations to ensure participant health and collect data on treatment effects over time.

Researchers are evaluating the safety and tolerability of Sacituzumab Tirumotecan when administered directly into the bladder for people with intermediate-risk non-muscle invasive bladder cancer (NMIBC). The study aims to find the highest dose that patients can take without experiencing serious problems and to select a dose level for future studies to assess how well the drug works. This is a Phase 1/2 open-label clinical trial focused on safety and efficacy in this specific bladder cancer population. Participants receive Sacituzumab Tirumotecan through intravesical administration, meaning the drug is given directly into the bladder. The study allows the use of rescue medications and supportive care to manage side effects such as stomatitis, oral mucositis, ocular surface toxicity, and other adverse events. Rescue medications may include antihistamines, steroids, antiemetics, antifungals, analgesics, and growth factors as deemed necessary by the investigator. During the study, researchers monitor participants closely for dose limiting toxicities, adverse events, and treatment discontinuations due to side effects, with primary outcomes assessed up to approximately 6 to 10 weeks. Participants undergo evaluations to assess safety and tolerability throughout the treatment period. The total duration and detailed follow-up procedures are designed to understand the drug’s safety profile and identify the optimal dose for further research.